ICH的GMP与中国GMP
: ICH的GMP背景和目的
: ICH的GMP的内容及 ICH的GMP和中国GMP的差异1
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一: ICH的GMP背景和目的
1: 概念:
1): ICH: the International Conference on Harmonization 国际人类药协作委员会: 主要包括: 美国, 日本, 欧洲 2): API: Active Pharmaceutical ingredient 药物有效成分
3):“Manufacturing, 生产” of ICH GMP guide is defined to include all operations of receipt of materials, production, packing, repackaging, labelling, relabelling, quality control, release, storage and distribution of APIS and related controls 2: 背景和目的
1996, 9月 Canberra 会议起草 ICH GMP (for APIs), 之后ICH的专家工作组, 主要来自世界三大制药地区: 美国, 日本, 欧洲 及其他国家: 如: 印度, 中国等代表。 目的:
it is intended to ensure that all APIs meet requirements for quality and purity which they purport or are represent to process. In a other words, “For the benefit of the patient on identifying the critical control and procedures that assure the quality of the APIS”. 3: ICH GMP的使用范围:
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Type of Application of this Guide to steps used in this type of manufacturing Manufacturing Chemical Production of Introduction Production of Isolation Physical Manufacturing the API of the API Intermediate(sand processing, Starting Starting ) purificatioand Material Material into n packaging process API extracted Collection of Cutting and Introduction of Isolation Physical from plant plant initial the API and processing, sources extraction(s) Starting purificatioand Material into n packaging process API derived Collection of Cutting, Introduction of Isolation Physical from animal organ, fluid, mixing, the API and processing, sources or tissue and/or initial Starting purificatioand processing Material into n packaging process Biotech/ Establishment Maintenance Cell culture Isolation Physical fermentation of master cell of working and/or and processing, cell culture bank and cell bank fermentation purificatioand working cell n packaging bank “Classical” Establishment Maintenance Introduction of Isolation Physical Fermentation of master cell of working the working and processing, to produce an bank cell bank cells into purificatioand API fermentation n packaging API consisting Collection of Cutting/ Physical of plants and/or comminuting processing, comminuted or cultivation and powdered and packaging herbs harvesting Herbal extracts Collection of Cutting and Further Physical used as API plants initial extraction processing, extraction and packaging
Increasing GMP requirments
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二: ICH的GMP的内容及ICH的GMP和中国GMP的差异
1: 总则 2: 质量管理 1):基本原理:
质量是从事生产的所有人员的职责,---
“GMP符合性并入质量管理体系这是欧洲质量哲学的理念” 2):质量部门的责任;
eg: process and control review, validation, change control, equipment qualification, batch documentation review, batch release, regulatory compliance, auditing, process deviation, OOS treatment and complaint investigation. 3):生产活动的职责 4): 内部审计
目的: 评价质量保证体系(或GMP原理)的符合性 5): 产品质量年度审核:
目的: 评价生产的符合性及改进的区域. 3: 人员
培训要求, 人员卫生, 咨询师 4: 厂房和设施
设计和结构, 动力, 水, 污染, 照明, 污水和废弃物, 卫生和维护 5: 工艺设备
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设计和结构, 设备维护和清洁, 校验, 计算机系统. 6: 文件和记录
1): 文件系统和规格 文件的版次, 文件(现有SOP)目录必须明确, 修订时间( 不超过2年), 文件的修订档案具有追溯性. 文件的保存时间
规格: 物料 materials
原料mat 其他原料 other mat 规格spec’s 关键critical 非关键non-critical spec’s optional 2): 设备的清洗和使用记录
建议使用时间顺序的日记: 3): 原料, 中间体, 标签和包装材料的记录
保存该类记录目的是: 跟踪从供应商的生产到产品销售到客户以防止物流链的差错
4):主生产记录 ( 包括主生产记录和控制记录) 5):实验室控制记录 6): 记录审核 7: 物料管理
8: 生产和生产过程的控制
1) 生产操作: 鉴别关键工序, 关键操作, 关键工艺参数 偏差调查, 关键偏差调查处理. 2):时间限制: 特别注意中间体的储存
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